Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Safety variables
研究概览
简要总结
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent for study participation and data submission (by the patient or legal representative for patients under 18) along with investigator/authorized physician signature.
- •Patients under 18 who have received age- and maturity-appropriate information per Article 63(2) MDR from trained investigators or team members; minors capable of understanding must also sign the informed consent.
- •The investigator must respect the decision of any minor, capable of understanding the information as per Article 63(2) MDR, to decline participation or withdraw from the clinical investigation at any time.
- •Ability to understand the nature and requirements of the study.
- •Patients with indication for renal replacement therapy, specifically PD (CAPD or APD)
- •Patients who began PD using FME catheters within the last 18 months and are either prevalent in PD at study initiation or have switched to HD or undergone transplantation and can consent to data use.
- •Incident patients who will begin PD using FME catheters.
排除标准
- •Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations,
- •Previous participation in the same study.
- •Life expectancy < 3 months.
研究组 & 干预措施
PD treatment
Include all the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study
结局指标
主要结局
Safety variables
时间窗: Every 6 months (± 2 months, as per centre practice)
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
次要结局
- Performance variables(very 6 months (± 2 months, as per centre practice))
- Outcome variables(very 6 months (± 2 months, as per centre practice))